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Published on 27 April 2015

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Bristol-Myers Squibb receives positive CHMP opinion of new ORENCIA® (abatacept)

Bristol-Myers Squibb Company (BMS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion in the European Union (EU) approving the ClickJect Pre-Filled Pen, a new autoinjector delivery device for ORENCIA (abatacept) for use in adult patients with moderate to severe active RA in combination with methotrexate after inadequate DMARD response. (1)

Bristol-Myers Squibb Company (BMS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion in the European Union (EU) approving the ClickJect Pre-Filled Pen, a new autoinjector delivery device for ORENCIA (abatacept) for use in adult patients with moderate to severe active RA in combination with methotrexate after inadequate DMARD response. (1)

New ClickJect Pre-Filled Pen designed for patients with moderate to severe active RA. Abatacept now offers a portfolio of three administration options available to fit patients’ lifestyles and individual treatment needs. (2,3,4)
Abatacept now offers a portfolio of three administration options, in the form of two subcutaneous (SC) self-injections; a pre-filled pen and the pre-filled syringe, as well as by intravenous infusion (IV). (2,3,4)

The new pre-filled pen offers patients with moderate to severe active RA a further administration option,” said Dr Andrew Östör, Director of the Rheumatology Clinical Research Unit, Addenbrooke’s Hospital, Cambridge. “This new delivery option provides patients the choice and flexibility they need in order to remain focused on their daily lives.

ClickJect (abatacept) Pre-Filled Pen includes:

  • A lightweight design and a textured, non-slip surface to aid grip.
  • A dark blue activation button that facilitates one-touch operation.
  • A large viewing window and a blue indicator that confirms the dose has been fully injected.  This may help patients have greater confidence that the dose has been completely delivered.
  • Step-by-step instructions to simplify the injection process and help ensure reliable administration.

We are committed to providing people with RA a range of delivery options to help fit their individual lifestyles and treatment needs,” said Johanna Mercier, General Manager, BMS, UK and Ireland.  “ClickJect gives patients greater flexibility in their treatment choice with the goal of providing an optimal treatment experience.

Abatacept is indicated for use in combination with methotrexate (MTX) to treat moderate to severe active RA in adults who have had an inadequate response to a disease-modifying anti-rheumatic drug (DMARD), including MTX or a tumour necrosis factor (TNF) antagonist (also known as an anti-TNF). (2,3,4)

References:

  1. CHMP opinion EMEA/H/C/000701/II/0087/G.
  2. Abatacept SC Summary of Product Characteristics April 2015. Available from www.medicines.org.uk.
  3. Abatacept IV Summary of Product Characteristics September 2014. Available from www.medicines.org.uk.
  4. Abatacept SC Summary of Product Characteristics April 2015. Available from www.medicines.org.uk.
  5. National Rheumatoid Arthritis Society. What is RA? Available at http://www.nras.org.uk/what-is-ra-article (Last accessed April 2015).
  6. National Rheumatoid Arthritis Society. The economic burden of rheumatoid arthritis. March 2010. http://www.nras.org.uk/data/files/Publications/1_economic_burden_of_ra_final_30_3_10.pdf.
  7. NHS choices. Rheumatoid arthritis. Overview. Available at http://www.nhs.uk/Conditions/Rheumatoid-arthritis/Pages/Introduction.aspx (Last accessed April 2015).
  8. Schiff M et al. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: two-year efficacy and safety findings from AMPLE trial. Ann Rheum Dis 2014;73:86–94.
  9. Smolen JS et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis 2014;73:492–509.


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